Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms which either occur spontaneously or as a result of environmental physical stimuli. Urticaria is known to severely impair the quality of life of affected patients. Thus, the majority of patients requires high-dosed antihistaminic drugs.
Conditions
Interventions
Trade Name: Ebastel 20mg Filmtabletten
Product Name: Ebastel 20mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: 4-diphenylmethoxy-1 [3-(4-ter-butylbenzoyl)-propyl] piperid
Sponsors
Allergie-Centrum-Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients with at least one of the following forms of physical urticaria for more than 6 weeks: 1) cold urticaria, 2) factitious dermographism. Urticarial symptoms must comprise wheal and itch. 2. History of beneficial effects of antihistaminic treatment. 3. History suggests association of performance impairment with increased disease activity. 4. Age between 18 and 70 years. 5. Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised. 6. Patients must be able and willing to assess and record symptom scores and to perform psychometric tests. 7. Voluntarily signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The presence of permanent severe diseases, especially those affecting the immune system, except physical urticaria. 2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract). 3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia. 4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. 5. Evidence of severe renal dysfunction 6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value). 7. History of adverse reactions to DPMP. 8. Presence of QT changes 9. Intake of medicaments that could cause QT changes 10. Presence of active cancer which requires chemotherapy or radiation therapy. 11. Presence of acute urticaria. 12. History or presence of alcohol abuse or drug addiction. 13. Participation in any clinical trial within 4 weeks prior to enrolment. 14. Itch of other origin. 15. Intake of antihistamines or leukotriene modifiers within 7 days prior to the beginning of the study 16. Intake of oral corticosteroids within 14 days prior to the beginning of the study 17. Use of depot corticosteroids or chronic inhaled or systemic corticosteroids within 21 days before beginning of the study 18. Intake of drugs affecting psychomotoric functions or alertness (e.g. antidepressants, anxiolytics, benzodiazepines). 19. Intake of CYP3A4-inhibitors 20. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show that DPMP (Ebastel®) compared to placebo is effective in protecting urticaria patients from the impairment of performance that results from the provocation of urticaria symptoms. Performance before and after provocation will be measured by a standardized and validated psychometric instrument (DAKT, Differential Attention Test). ;Secondary Objective: Change in the ability to cope with pressure after provocation Vienna Determination Test (DT) which allows for the assessment of the exhaustion in mental speed tasks. Change in mood after provocation Changes in patients’ mood will be assessed using the Profile of Mood States (POMS). This test is constructed as a list of adjectives. The following scales are examined: 1) Depression-Dejection, 2) Anger-Hostility, 3) Vigor-Activity, 4) Fatigue-Inertia. Change in urticaria symptoms Urticaria symptoms will be assessed using scores for numbers and sizes of wheals and erythemas and intensity of pruritus respectively burning using a modified version of the urticaria-activity score of Greaves. Change in patients’ evaluation of urticaria activity Changes of symptoms as assessed by the patients will be determined using an even numbered Likert scale. ;Primary end point(s): The main goal of the analysis is to test whether a single dose of 20 mg DPMP (Ebastel®) is effective in protecting urticaria patients from the impairment of performance that results from the provocation of urticaria symptoms. The primary efficacy parameter of the study is the change in test score values after provocation (DAKT). | — |
Countries
Germany
Outcome results
None listed